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Clinical Trials Monthly - April 2013

Clinical trials help us increase our knowledge about cancer and develop more effective, less toxic treatments. Each month we publish this newsletter with our Hotlist of the newest clinical trials that might be of interest to you and your patients. In this issue, we feature trials for colorectal cancer, lung cancer, and lymphoma.

Colorectal Cancer

Lung Cancer

Lymphoma

Breakthrough Breast Cancer Treatment — "A Magic Bullet"

The U.S. Food & Drug Administration approved T-DM1 for the treatment of HER2-positive breast cancer in February. The drug (trade name Kadcyla), was the subject of several clinical trials here at SCCA and has been hailed as a breakthrough cancer treatment because of the way it targets tumor cells.

SCCA medical oncologist, Julie Gralow, MD considers T-DM1 to be a “magic bullet” for patients with HER2-positive breast cancer. She explains why in a video about T-DM1. 

Colorectal Cancer with Liver Metastasis

TheraSphere® Metastatic Colorectal Carcinoma of the Liver (7627)

A Phase III Clinical Trial Evaluating TheraSphere in Patients with Metastatic Colorectal Carcinoma of the Liver who have Failed First-Line Chemotherapy

This study will evaluate the efficacy and safety of TheraSphere® in patients with metastatic colorectal cancer of the liver who are scheduled to receive second-line standard-of-care chemotherapy of either an irinotecan-based regimen, usually FOLFIRI, or an oxaliplatin-based regimen, usually FOLFOX.

TheraSphere, containing yttrium-90 glass microspheres, is used for the treatment of hepatic neoplasia in the European Union. It is approved in Canada for treatment of hepatic neoplasia in patients who have appropriately positioned arterial catheters. In the United States, TheraSphere is approved for commercial distribution under a Humanitarian Device Exemption (HDE) for use in radiation treatment or as a neoadjuvant to surgery or transplantation in patients with unresectable hepatocellular carcinoma (HCC) who can have appropriately positioned hepatic arterial catheters placed. The device is also indicated for HCC patients with partial or branch portal vein thrombosis/occlusion when clinical evaluation warrants the treatment. Investigator: William P. Harris, MD

Lung Cancer

ABRAXANE® (Nab-Paclitaxe l) for Advanced NSCLC (7755)

A Phase II Study of Weekly ABRAXANE® (Nab-Paclitaxel) for Patients with Advanced NSCLC with EGFR Mutations Following Front-line Therapy with EGFR Tyrosine Kinase Inhibitors

This study will evaluate the overall response rate to weekly nab-paclitaxel in patients with advanced non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) mutations following front-line therapy with EGFR tyrosine kinase inhibitors (TKI). These patients represent 10 to 15 percent of advanced NSCLC and show remarkable sensitivity to EGFR TKIs such as erlotinib and gefitinib. However, most patients experience disease progression after approximately one year and will require second-line therapy. Evidence indicates that these patients may also be sensitive to taxane-based therapies.

ABRAXANE is a biologically interactive nanoparticle albumin-bound paclitaxel. By combining a protein with a chemotherapeutic agent in particle form, this composition increases intra-tumoral concentrations of the drug by receptor-mediated transport, a process that facilitates transcytosis across the endothelial cell.

This is an SCCA investigator-initiated study that is open to SCCA patients and patients at the following SCCA Network sites: Bozeman Deaconess Hospital, Columbia Basin Hematology and Oncology, Group Health Cooperative, MultiCare Health Systems, Olympic Medical Center, and Skagit Valley Hospital. Investigator: Christina Baik, MD, MPH

Lymphoma

Brentuximab Vedotin for Relapsed or Refractory CD30+ Lymphoma (FH 7808)

A Pilot Study of Weekly Brentuximab Vedotin in Patients with CD30+ Malignancies Refractory to Every >= 3 Week Brentuximab Vedotin

Brentuximab vedotin (Adcetris™) is an antibody drug conjugate (ADC). The brentuximab vedotin targets CD30, found on some cancer cells and some normal cells of the immune system. The chemotherapy is an antimitotic called monomethyl auristatin E (MMAE). MMAE kills the cells that the anti-CD30 sticks to. Brentuximab vedotin is FDA-approved for certain lymphomas. However, some patients’ cancer stays the same or gets worse after treatment with brentuximab vedotin at the approved dose. This study looks at the effects of giving treatment more frequently and at a lower dose. Investigator: Ajay K. Gopal, MD

DCDT2980S or DCDS4501A in Combination with Rituximab for Relapsed Lymphoma (FH 2649) 

A Randomized, Open-Label, Multicenter, Phase II Trial Evaluating the Safety and Activity of DCDT2980S in Combination with Rituximab or DCDS4501A in Combination with Rituximab in Patients with Relapsed or Refractory B-cell Non-Hodgkin’s Lymphoma

This study will randomize patients to one of two experimental ADCs, DCDT2980S or DCDS4501A, along with rituximab for patients who have failed or relapsed after treatment with other NHL therapies. Because the toxicity of the drugs is very low, and because these patients have few other effective options, the study is a high priority for researchers and clinicians.

DCDT2980S and DCDS4501A were designed to inhibit tumor growth. They target specific markers on the surface of tumor cells: CD22 and CD79b. In the laboratory, DCDT2980S and DCDS4501A reduced the growth of a number of B-cell malignancies including lymphomas. Rituximab has been tested in combination with DCDT2980S or DCDS4501A but more information regarding the combination is needed. Investigator: Oliver W. Press, MD, PhD

Trials Hotlist

NCI Designation

Disease Site

Trial Description

NCT01439347

ALL

 A Phase III, Multicenter, Randomized Study to Evaluate the Substitution of Marqibo® (Vincristine Sulfate Liposomes Injection, VSLI) for Standard Vincristine Sulfate Injection (VSI) in the Induction, Intensification, and Maintenance Phases of Combination Chemotherapy in the Treatment of Subjects = 60 Years Old with Newly Diagnosed Acute Lymphoblastic Leukemia (ALL)

NCT01565668

AML

A Phase II, Randomized, Open-Label Study of the Safety and Efficacy of Two Doses of Quizartinib (AC220; ASP2689) in Subjects with FLT3-ITD Positive Relapsed or Refractory Acute Myeloid Leukemia (AML)

NCT01701323

AML

Pilot Study Evaluating the Use of Ex Vivo Expanded Cord Blood Progenitors as Supportive Care Following Induction Chemotherapy (FLAG) in Patients with Relapsed/Refractory AML

NCT01729845

AML/MDS

Mitoxantrone, Etoposide, and Cytarabine (MEC) Following Epigenetic Priming with Decitabine in Adults with Relapsed/Refractory Acute Myeloid Leukemia (AML) or High-Risk Myelodysplastic Syndromes (MDS): A Phase I/II Study

NCT01632852

AML

A Phase I Study of CSL362 (Anti-IL3Ra / Anti-CD123 Monoclonal Antibody) in Patients with CD123+ Acute Myeloid Leukemia in Complete Remission or Complete Remission with Incomplete Platelet Recovery at High Risk for Early Relapse

NCT01756677

AML

A Phase I/II Study of Low Dose Cytarabine and Lintuzumab-Ac225 in Older Patients with Untreated Acute Myeloid Leukemia

NCT01696084

AML

Phase III, Multicenter, Randomized, Trial of CPX-351 (Cytarabine: Daunorubicin) Liposome Injection Versus Cytarabine and Daunorubicin in Patients 60-75 Years of Age with Untreated High Risk (secondary) AML

NCT01611974

Bone Marrow Transplant

A Phase II, Randomized Study to Assess the Safety and Anti-Cytomegalovirus (CMV) Activity of Different Doses of Maribavir for Treatment of CMV Infections that are Resistant or Refractory to Treatment with Ganciclovir/Valganciclovir or Foscarnet in Transplant Recipient

NCT01691248

Bone Marrow Transplant

DEFLECT-1: A Phase IIIb Multicenter, Double-Blind, Randomized, Placebo Controlled Study to Demonstrate the Safety and Efficacy of Fidaxomicin for Prophylaxis against Clostridium Difficile-Associated Diarrhea in Adults Undergoing Hematopoietic Stem Cell Transplantation

NCT00626990

Brain Cancer

Phase III Trial on Concurrent and Adjuvant Temozolomide Chemotherapy in Non-1P/19Q Deleted Anaplastic Glioma: The CATNON Intergroup Trial (RTOG 0834)

NCT01492101

Breast Cancer

The BEACON Study (Breast Cancer Outcomes with NKTR-102): A Phase III Open-Label, Randomized, Multicenter Study of NKTR-102 Versus Treatment of Physician's Choice (TPC) in Patients with Locally Recurrent or Metastatic Breast Cancer Previously Treated with an Anthracycline, a Taxane and Capecitabine

NCT01720602

Breast Cancer

A Pilot Study of Vorinostat to Restore Sensitivity to Aromatase Inhibitor Therapy Part B

NCT01650805

CML

A Phase III Randomized, Open-Label Study of Ponatinib versus Imatinib in Adult Patients with Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase

NCT01479465

Colorectal Cancer

A Phase II Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of GS-6624 Combined with FOLFIRI as Second Line Treatment for Metastatic KRAS Mutant Colorectal Adenocarcinoma that has Progressed Following a First-Line Oxaliplatin- and Fluoropyrimidine-Containing Regimen

NCT01483027

Colorectal Cancer

A Phase III Clinical Trial Evaluating TheraSphere® in Patients with Metastatic Colorectal Carcinoma of the Liver Who Have Failed First Line Chemotherapy

NCT01609231

Colorectal Cancer

A Phase IIA Open Label, Adaptive, Randomized Clinical Trial of Dalotuzumab (MK-0646) Treatment in Combination with Irinotecan Versus Cetuximab and Irinotecan for Patients with Metastatic Rectal Cancers (mRC) Expressing High IGF-1/Low IGF-2 Levels

NCT01642082

Endometrial Cancer

A Phase II Evaluation of Dalantercept, A Novel Soluable Recombinant Activin Receptor-Like Kinase 1 (ALK-1) Inhibitor Receptor-Fusion Protein, in Treatment of Recurrent or Persistent Endometrial Carcinoma

NCT01196390

Esophageal Cancer

A Phase III Trial Evaluating the Addition of Trastuzumab to Trimodality Treatment of HER2-Overexpressing Esophageal Adenocarcinoma

NCT01333033

Esophageal Cancer

Randomized Phase II Trial of PET Scan-Directed Combined Modality Therapy in Esophageal Cancer

NCT01091428

Gynecologic Cancers

Randomized Phase II Study of MLN8237, an Aurora A Kinase Inhibitor, Plus Weekly Paclitaxel or Weekly Paclitaxel Alone in Patients with Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer, Preceded by a Phase I Portion in Patients with Ovarian or Breast Cancer

NCT01412229

Head & Neck Cancer

A Phase II Study of Carboplatin, Nab-paclitaxel and Cetuximab for Induction Chemotherapy for Locally Advanced Squamous Cell Carcinoma of the Head and Neck

NCT01690520

Leukemia

Multicenter, Open-Label Randomized Study of Single or Double Myeloablative Cord Blood Transplantation with or without Infusion of Off-the-shelf ex Vivo Expanded Cryopreserved Cord Blood Progenitor Cells in Patients with Hematologic Malignancies

NCT01287585

Liver Cancer

POLARIS2009-001: A Randomized, Double-Blind, Multicenter Phase III Study of ADI PEG 20 Plus Best Supportive Care (BSC) Versus Placebo Plus BSC in Subjects With Advanced Hepatocellular Carcinoma (HCC) Who Have Failed Prior Systemic Therapy

NCT01673867

Lung Cancer

An Open-Label Randomized Phase III Trial of BMS-936558 Versus Docetaxel in Previously Treated or Metastatic Non-Squamous Non-Small Cell Lung Cancer (NSCLC)

NCT01712217

Lung Cancer

A Study of HSP90 Inhibitor AT13387 Alone and in Combination with Crizotinib in the Treatment of Non-Small Cell Lung Cancer (NSCLC)

NCT01642004

Lung Cancer

An Open-Label Randomized Phase III Trial of BMS-936558 Versus Docetaxel in Previously Treated Advanced or Metastatic Squamous Cell Non-Small Cell Lung Cancer (NSCLC)

NCT01621490

Melanoma

An Exploratory Study of the Biologic Effects of BMS-936558 (Anti-PD-1 Monoclonal Antibody) Treatment in Subjects with Advanced Melanoma (Unresectable or Metastatic)

NCT01758458

Merkel Cell Carcinoma

Study to Evaluate Cellular Adoptive Immunotherapy Using Polyclonal Autologous CD8+ Antigen-Specific T Cells for Metastatic Merkel Cell Carcinoma

NCT01660750

Multiple Myeloma

A Multicenter Phase Ib, Open-Label, Dose-Finding Pilot Study to Evaluate the Combination of Carfilzomib and Cyclophosphamide with Dexamethasone Prior to Autologous Stem Cell Transplant in Patients with Transplant Eligible Newly Diagnosed Multiple Myeloma

NCT01360853

Pancreatic Cancer

A Phase II/III, Multicenter, Randomized, Controlled Study to Compare the Efficacy and Safety of Gemcitabine Alone vs. ON 01910.Na Combined with Gemcitabine in Patients with Previously Untreated Metastatic Pancreatic Cancer

NCT01503229

Prostate Cancer

Open Label Pharmacodynamic Study of Abiraterone in the Treatment of Metastatic, Castration Resistant Prostate Cancer

NCT01283373

Prostate Cancer

A Study of the Safety and Pharmacokinetics of Escalating Doses of DSTP3086S in Patients With Metastatic Castration-Resistant Prostate Cancer

NCT01106352

Prostate Cancer

A Study of Alpharadin® With Docetaxel in Patients With Bone Metastasis From Castration-Resistant Prostate Cancer (CRPC)

NCT01667536

Prostate Cancer

A Phase II Assessment of the Diagnostic Accuracy of Tc-MIP-1404 Imaging in Men with High-Risk Prostate Cancer Scheduled for Radical Prostatectomy and Extended Pelvic Lymph Node Dissection Compared to Histopathology

NCT01574716

Sarcoma

A Study of the Safety and Efficacy of the Combination of Gemcitabine and Docetaxel in Metastatic Soft Tissue Sarcoma

NCT01602211

Survivorship

INSPIRE for Survivorship after Transplant: A Multicenter Randomized Controlled Trial of an Internet and Social-Media Program for Long-Term Hematopoietic Cell Transplantation Survivors



Adult Bone Marrow Transplant News

The SCCA Adult Bone Marrow Transplant News is a publication presenting the latest information on bone marrow transplant research at SCCA, providing up-to-date information for all health care professionals caring for transplant patients.

Pediatric Bone Marrow Transplant News

Read about important outcomes research at the Hutchinson Center that may benefit your patients.

Clinical Trials Monthly

Each issue of Clinical Trials Monthly highlights several of the more than 200 clinical trials that are currently recruiting patients at SCCA.

The Leading Edge Newsletter

Each quarterly Leading Edge newsletter will highlight a new topic to give you the latest news on leading-edge therapies that SCCA physicians are offering.